FDA Device recall Z-2183-2016
Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 Neurology: Target Detachable Coils are intended to endova…
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 Neurology: Target Detachable Coils are intended to endova… by Stryker Neurovascular, citing stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resista….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2183-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-06 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Neurovascular |
| Distribution | US |
Product
Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Reason
Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
Identifiers
| code_info | MODEL Number:M0035452540; Lot Number/Expiration Date: 18440351 30-Jun-18 18539018 31-Aug-18 18439805 30-Jun-18 1…MODEL Number:M0035452540; Lot Number/Expiration Date: 18440351 30-Jun-18 18539018 31-Aug-18 18439805 30-Jun-18 18519562 31-Jul-18 18468754 30-Jun-18 18922401 31-Mar-19 19060307 31-May-19 18970593 30-Apr-19 18898116 28-Feb-19 19034354 31-May-19 18875384 28-Feb-19. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2183-2016%22
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